Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma (PDAC)

St. Olavs Hospital

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Pancreatic Ductal

Treatments: Drug: Chemotherapy; Combination Product: SonoVue

Study type: Interventional

Funder types: Other

Identifiers

NCT04146441

2019-001736-57 (EudraCT Number)

040376MH

Details and patient eligibility

About

Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.

Enrollment: 20 patients

Sex: All

Ages: 19 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
• eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
• ECOG 0 - 1

Exclusion criteria

• Known contraindications for SonoVue
• Hematological bleeding status before experimental treatment:
• Hb < 8g/dL, trc < 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

SonoVue

Experimental group

Description:

SonoVue + chemotherapy

Treatment:

Combination Product: SonoVue

Drug: Chemotherapy

control

Active Comparator group

Description:

chemotherapy

Treatment:

Drug: Chemotherapy